Part 870 Subpart E—Cardiovascular Surgical Devices
FDA submissions for Part 870 Subpart E—Cardiovascular Surgical Devices in the Cardiovascular (CV) review panel, including product codes and regulations.
Section range: §§ 870.4075–870.4885
CFR Part: 870
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| DWZ | Device, Biopsy, Endomyocardial | 870.4075 | 2 | 23 |
| MFY | Endothelial Cell Harvesting Kit | 870.4075 | 2 | 1 |
| OFG | Ct Biopsy Tray | 870.4075 | 2 | 0 |
| BYS | Oxygenator, Long Term Support Greater Than 6 Hours | 870.4100 | 2 | 3 |
| PZS | Dual Lumen Ecmo Cannula | 870.4100 | 2 | 4 |
| QHW | Single Lumen Ecmo Cannula | 870.4100 | 2 | 3 |
| QJZ | Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure | 870.4100 | 2 | 3 |
| QNR | Blood Pump For Ecmo, Long-Term (> 6 Hours) Use | 870.4100 | 2 | 8 |
| QWF | Tubing, Long Term Support Greater Than 6 Hours | 870.4100 | 2 | 1 |
| QOH | Extracorporeal System For Carbon Dioxide Removal | 870.4150 | 2 | 1 |
| KRI | Accessory Equipment, Cardiopulmonary Bypass | 870.4200 | 1 | 42 |
| KRL | Detector, Bubble, Cardiopulmonary Bypass | 870.4205 | 2 | 14 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 870.4210 | 2 | 400 |
| OEU | Cardiopulmonary Bypass Catheter Kit | 870.4210 | 2 | 0 |
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 870.4220 | 2 | 52 |
| DTP | Defoamer, Cardiopulmonary Bypass | 870.4230 | 2 | 34 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 870.4240 | 2 | 91 |
| OET | Cardioplegia Solution Administration Kit | 870.4240 | 2 | 0 |
| DWC | Controller, Temperature, Cardiopulmonary Bypass | 870.4250 | 2 | 30 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 870.4260 | 2 | 96 |
| JOD | Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass | 870.4270 | 2 | 12 |
| KRJ | Filter, Prebypass, Cardiopulmonary Bypass | 870.4280 | 2 | 24 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 870.4290 | 2 | 137 |
| DTX | Gas Control Unit, Cardiopulmonary Bypass | 870.4300 | 2 | 10 |
| DXS | Gauge, Pressure, Coronary, Cardiopulmonary Bypass | 870.4310 | 2 | 13 |
| JOR | Generator, Pulsatile Flow, Cardiopulmonary Bypass | 870.4320 | 3 | 0 |
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 870.4330 | 2 | 47 |
| DTW | Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass | 870.4340 | 2 | 17 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 870.4350 | 2 | 254 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 870.4360 | 2 | 84 |
| PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | 870.4360 | 3 | 1 |
| DWB | Pump, Blood, Cardiopulmonary Bypass, Roller Type | 870.4370 | 2 | 21 |
| DWA | Control, Pump Speed, Cardiopulmonary Bypass | 870.4380 | 2 | 37 |
| DWE | Tubing, Pump, Cardiopulmonary Bypass | 870.4390 | 2 | 21 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 870.4400 | 2 | 169 |
| MJJ | Cpb Check Valve, Retrograde Flow, In-Line | 870.4400 | 2 | 9 |
| MNJ | Valve, Pressure Relief, Cardiopulmonary Bypass | 870.4400 | 2 | 2 |
| PTN | Reservoir, Blood, Cardiopulmonary Bypass, Exempt | 870.4400 | 2 | 0 |
| DTY | Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass | 870.4410 | 2 | 8 |
| DTS | Sucker, Cardiotomy Return, Cardiopulmonary Bypass | 870.4420 | 2 | 9 |
| DWD | Suction Control, Intracardiac, Cardiopulmonary Bypass | 870.4430 | 2 | 15 |
| DXC | Clamp, Vascular | 870.4450 | 2 | 202 |
| MJN | Catheter, Intravascular Occluding, Temporary | 870.4450 | 2 | 90 |
| NMF | Clamp, Vascular, Reprocessed | 870.4450 | 2 | 3 |
| DWP | Dilator, Vessel, Surgical | 870.4475 | 2 | 20 |
| DWS | Instruments, Surgical, Cardiovascular | 870.4500 | 1 | 71 |
| LXN | Probe, Test, Heart-Valve | 870.4500 | 1 | 2 |
| MWS | Stabilizer, Heart | 870.4500 | 1 | 4 |
| NQG | Stabilizer, Heart, Non-Compression, Reprocessed | 870.4500 | 1 | 3 |
| OFA | Cardiovascular Surgical Instruments Tray | 870.4500 | 1 | 0 |
| PNQ | Apical Closure Device | 870.4510 | 2 | 1 |
| QVQ | Extravascular Support For An Arteriovenous Fistula For Vascular Access | 870.4600 | 2 | 2 |
| DWX | Stripper, Artery, Intraluminal | 870.4875 | 2 | 14 |
| MCW | Catheter, Peripheral, Atherectomy | 870.4875 | 2 | 146 |
| QTF | Reprocessed Atherectomy Catheter | 870.4875 | 2 | 1 |
| DWQ | Stripper, Vein, External | 870.4885 | 2 | 8 |
| MGZ | Valvulotome | 870.4885 | 2 | 27 |
| NLJ | Stripper, Vein, External, Reprocessed | 870.4885 | 2 | 0 |
